Development of an Optimal Antibiotic Regime for Long-term Therapy in Stable Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease (COPD) is the cause of considerable deaths, and exacerbations (flare up of symptoms) are a major cause of hospital admission in the UK. Bacterial infections play an important role in the development of COPD, however, there is little information available about the use of long term antibiotics in the treatment of this disease. Therefore the purpose of this study is to identify the best antibiotic regime for treating patients with COPD who have persistent bacterial infection in their lung. We will test a variety of approaches including both older and newer regimes prescribed either on a daily basis at a lower dose or in "pulsed" courses (for example, every other day or five days every month). The three antibiotics tested in this study are: moxifloxacin, azithromycin and doxycycline. This is a 13 weeks study conducted at the Royal Free Hospital, London. It is expected that approximately 200 patients will be selected for this study. The information we get from this study may help us to treat future patients with COPD better.
Chronic Obstructive Pulmonary Disease (COPD).
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
|Official Title:||A Phase III Single-blind, Randomised Placebo Controlled Trial of Long Term Therapy in Patients With Stable COPD Using Moxifloxacin, Azithromycin and Doxycycline: a Bayesian Decision Analysis, Including Other Criteria, Will be Used to Distinguish the Optimal Antibiotic Treatment|
- To measure and compare reduction in the concentration of lower airway bacteria in patients with COPD between three different antibiotic regimes and placebo [ Time Frame: Week 14 post treatment ] [ Designated as safety issue: No ]
- To measure changes in lung function measure, health status and exacerbations. [ Time Frame: week 14 post treatment ] [ Designated as safety issue: No ]
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: Moxifloxacin||
An oral dose of 400 mg once daily for 5 consecutive days every 4 weeks.
|Active Comparator: Azithromycin||
An oral dose of 250 mg once daily three times a week (every other day).
|Active Comparator: Doxycycline||
An oral dose of 100 mg once daily.
|Placebo Comparator: Placebo||
Oral dose of one table once daily.
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|Contact: Ethaar El-Emir, PhD||0044 firstname.lastname@example.org|
|Academic Unit of Respiratory Medicine, Royal Free Hospital||Recruiting|
|London, United Kingdom, NW3 2PF|
|Contact: Ethaar El-Emir, PhD 0044 2073177510 email@example.com|
|Principal Investigator: Jadwiga A Wedzicha, MA, MD, FRCP|
|Principal Investigator:||Jadwiga A Wedzicha||University College, London|